JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
FDA Recall Z-1045-2019 · Posted None
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-12-10
Date Terminated2020-11-03
Product Quantity46 units
Reason for Recall
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Firm Action
The firm, smith&nephew, initiated the recall by email with an "Urgent Medical Device Recall Notice" letter dated 12/10/18 to the customers on 12/10/2018. Letter describes the product, problem and actions to be taken. The customers were instructed to do the following:
-Inspect your inventory and locate any devices from the listed product and batch numbers and quarantine them immediately.
- If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out.
-Complete and return the Response Form to [email protected] or fax to 901-566-7975.
Please Note even if you have no product to return, this form must be completed, signed and returned.
If you have any questions or concerns regarding this recall please contact [email protected].
Root Cause
Device Design
Distribution Pattern
US Distribution to OR and TN; and Internationally to: Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.